| CTRI Number |
CTRI/2010/091/002807 [Registered on: 03/11/2010] |
| Last Modified On: |
28/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
A clinical trial to see whether an alternate vaccination schedule of the killed oral cholera vaccine is as immunogenic as the standard vaccine schedule |
Scientific Title of Study
Modification(s)
|
A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE IMMUNOGENICITY OF TWO DOSES OF THE MODIFIED KILLED WHOLE CELL ORAL CHOLERA VACCINE (WC-OCV) UNDER TWO ALTERNATIVE VACCINATION SCHEDULES |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT01233362 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dipika Sur |
| Designation |
Scientist-F |
| Affiliation |
National institute of cholera and enteric diseases(NICED) |
| Address |
P-33,CIT Road
Scheme-XM, Beliaghata
Kolkata
WEST BENGAL
700010
India |
| Phone |
91-33-2336-3374 |
| Fax |
91-33-2363-5066 |
| Email |
dipikasur@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Suman Kanungo |
| Designation |
Scientist-B |
| Affiliation |
National Institute of Cholera and Enteric Diseases(ICMR) |
| Address |
P-33,CIT Road
Scheme-XM, Beliaghata
Kolkata
WEST BENGAL
700010
India |
| Phone |
91-33-2336-3374 |
| Fax |
91-33-2363-5066 |
| Email |
kanungosuman@rediffmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dipika Sur |
| Designation |
Scientist-F |
| Affiliation |
National institute of cholera and enteric diseases(NICED) |
| Address |
P-33,CIT Road
Scheme-XM, Beliaghata
Kolkata
WEST BENGAL
700010
India |
| Phone |
91-33-2363-3374 |
| Fax |
91-33-2370-5066 |
| Email |
dipikasur@hotmail.com |
|
|
Source of Monetary or Material Support
|
| International Vaccine Institute,Seoul, Korea |
|
Primary Sponsor
Modification(s)
|
| Name |
International Vaccine InstituteSeoul Korea |
| Address |
Seoul National university campus,Shilim Dong,Kwan-ku,Seoul,Korea |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dipika Sur |
National Institute of Cholera and Cholera and Enteric Diseases |
P-33 CIT Road,Scheme-XM,Beliaghata-700010
Kolkata
WEST BENGAL |
91-33-2363-3374
91-33-2370-5066
dipikasur@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NICED IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To study the safety and immunogenicity of the killed oral cholera a vaccine under two alternate dosing schedules among healthy non pregnant volunteers aged 1 year and above |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Heat and formalin killed strains of E.coli K12 |
2doses 1.5ml |
| Intervention |
Modified Killed Whole Cell Oral cholera Vaccine (Shancol) |
2 doses of 1.5 ml each 2 weeks and 4 weeks apart (alternate schedule) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 - 17 will be recruited in Kolkata.
All subjects must satisfy the following criteria at study entry:
1. Males or non-pregnant females aged 18 years and above and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
2. Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 ? 17 years.
3. Healthy subjects as determined by:
Medical history
Physical examination
Clinical judgment of the investigator
|
|
| ExclusionCriteria |
| Details |
The following criteria should be checked at the time of study entry, if any of the following is present then the subject will be excluded from the study:
1. Ongoing serious chronic disease
2. For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
3. Immunocompromising condition or therapy (for corticosteroids this would mean ≥0.5 mg/kg/day)
4. Diarrhea (3 or more loose/watery stools within a 24-hour period) 6 weeks prior to enrollment
5. One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
6. One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
7. Intake of any anti-diarrhea medicine in the past week
8. Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
9. Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC warrants deferral of the vaccination pending recovery of the subject
10. Receipt of immunoglobulin or any blood product during the past 3 months
11. Receipt of antibiotics in past 14 days
12. Receipt of live or killed enteric vaccine in past 4 weeks
13. Receipt of killed oral cholera vaccine
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after last dose of study agent in each dose-interval group |
Primary Time point is the measurement of serum vibriocidal titres,relative to baseline, 14 days after last dose of study agent in each dose-interval group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after first dose of study agent
2. Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the study agent, in each dose-interval group.
3. Proportion of subjects given 2 doses of study agent given 14 and 28 days apart with any of the following adverse events:
a. Immediate reactions within 30 minutes after each dose
b. Serious Adverse Events occurring throughout the trial
c. Reactogenicity during three consecutive days following each dose: Headache, vomiting, nausea, abdominal pain/cramps, gas, diarrhea, fever, loss of appetite, general ill feeling
i. Diarrhea is defined as having 3 or more loose/watery stools within a 24 hour period.
ii. Fever is defined as having an oral or tympanic temperature of ≥38o C
|
For Safety:
a. Immediate reactions within 30 minutes after each dose
b. Serious Adverse Events occurring throughout the trial
c. Reactogenicity during three consecutive days following each dose:
For immunogenicity:
14 days after each dose of the study agent, in each dose-interval group |
|
Target Sample Size
Modification(s)
|
Total Sample Size="386"
Sample Size from India="386"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
15/11/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a placebo controlled double blind,randomized trial aimed to see whether the killed oral cholera avccine (Shancol) that is available in India are more immunogenic if the dosing interval between the two doses are increased,as evident from earlier findings where it has been shown that there is higher immune response following first dose than after the second dose given at 2 weeks interval. For the main study the sample size is 356,aged 1-17 yeras and 18 yeras and above. Additional 30 volunteers will be recruited for exploration of alternate assays to see the immune response to this vaccine |